Antiplatelet Therapy Duration Following Bare Metal or Drug-Eluting Coronary Stents: the Dual Antiplatelet Therapy Randomized Clinical Trial
Identifieur interne : 003164 ( Main/Exploration ); précédent : 003163; suivant : 003165Antiplatelet Therapy Duration Following Bare Metal or Drug-Eluting Coronary Stents: the Dual Antiplatelet Therapy Randomized Clinical Trial
Auteurs : Dean J. Kereiakes ; Robert W. Yeh ; Joseph M. Massaro ; Priscilla Driscoll-Shempp ; Donald E. Cutlip ; P. Gabriel Steg ; Anthony H. Gershlick ; Harald Darius ; Ian T. Meredith ; John Ormiston ; Jean Francois Tanguay ; Stephan Windecker ; Kirk N. Garratt ; David E. Kandzari ; David P. Lee ; Daniel I. Simon ; Adrian Corneliu Iancu ; Jaroslaw Trebacz ; Laura MauriSource :
- JAMA [ 0098-7484 ] ; 2015.
Abstract
Despite antirestenotic efficacy of coronary drug-eluting stents (DES) compared with bare metal stents (BMS), the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Although dual antiplatelet therapy (DAPT) beyond one year provides ischemic event protection following DES, ischemic event risk is perceived to be less following BMS and the appropriate duration of DAPT following BMS is unknown.
To compare: (1) rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE; composite of death, myocardial infarction, or stroke) after 30 vs. 12 months of thienopyridine in patients treated with BMS taking aspirin; and (2) treatment duration effect within the combined cohorts of randomized DES or BMS-treated patients as prespecified, secondary analyses of the Dual Antiplatelet Therapy Study.
International, multicenter, randomized, double-blinded, placebo-controlled trial, comparing extended (30 months) thienopyridine versus placebo in aspirin-treated patients who completed 12 months of DAPT without bleeding or ischemic events post-stenting. Study initiation August 2009 with last follow-up visit May 2014.
Continued thienopyridine or placebo at months 12-30 after stenting, in 11648 randomized patients treated with aspirin, of whom 1687 received BMS and 9961 DES.
Stent thrombosis, MACCE, moderate/severe bleeding.
Among 1687 BMS-treated patients randomized to continued thienopyridine vs. placebo, rates of stent thrombosis were 0.5% vs. 1.11%, (N=4 vs. 9, hazard ratio 0.49, 95% CI 0.15-1.64, P=0.24), MACCE 4.04% vs. 4.69%, (N=33 vs. 38, hazard ratio 0.92, 95% CI 0.57-1.47, P=0.72) and moderate/severe bleeding 2.03% vs. 0.90% (N=16 vs. 7, P=0.07), respectively. Among all 11,648 randomized patients (both BMS- and DES-treated), stent thrombosis rates were 0.41% vs. 1.32%, (N=23 vs. 74, hazard ratio 0.31, 95% CI 0.19-0.50, P<0.001), MACCE 4.29% vs. 5.74% (N=244 vs. 323, hazard ratio 0.73, 95% CI 0.62-0.87, P<0.001), and moderate/severe bleeding 2.45% vs. 1.47% (N=135 vs. 80, P<0.001).
Among patients undergoing coronary stenting with BMS and who tolerated 12 months of thienopyridine, continuing thienopyridine for an additional 18 months compared with placebo did not result in statistically significant differences in rates of stent thrombosis, MACCE, or moderate/severe bleeding. However, the BMS subset may have been underpowered to identify such differences and further trials are suggested. (DAPT ClinicalTrials.gov number NCT00977938).
Url:
DOI: 10.1001/jama.2015.1671
PubMed: 25781440
PubMed Central: 4481320
Affiliations:
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Kereiakes</name></author><author><name sortKey="Yeh, Robert W" sort="Yeh, Robert W" uniqKey="Yeh R" first="Robert W." last="Yeh">Robert W. Yeh</name></author><author><name sortKey="Massaro, Joseph M" sort="Massaro, Joseph M" uniqKey="Massaro J" first="Joseph M." last="Massaro">Joseph M. Massaro</name></author><author><name sortKey="Driscoll Shempp, Priscilla" sort="Driscoll Shempp, Priscilla" uniqKey="Driscoll Shempp P" first="Priscilla" last="Driscoll-Shempp">Priscilla Driscoll-Shempp</name></author><author><name sortKey="Cutlip, Donald E" sort="Cutlip, Donald E" uniqKey="Cutlip D" first="Donald E." last="Cutlip">Donald E. Cutlip</name></author><author><name sortKey="Steg, P Gabriel" sort="Steg, P Gabriel" uniqKey="Steg P" first="P. Gabriel" last="Steg">P. Gabriel Steg</name></author><author><name sortKey="Gershlick, Anthony H" sort="Gershlick, Anthony H" uniqKey="Gershlick A" first="Anthony H." last="Gershlick">Anthony H. Gershlick</name></author><author><name sortKey="Darius, Harald" sort="Darius, Harald" uniqKey="Darius H" first="Harald" last="Darius">Harald Darius</name></author><author><name sortKey="Meredith, Ian T" sort="Meredith, Ian T" uniqKey="Meredith I" first="Ian T." last="Meredith">Ian T. Meredith</name></author><author><name sortKey="Ormiston, John" sort="Ormiston, John" uniqKey="Ormiston J" first="John" last="Ormiston">John Ormiston</name></author><author><name sortKey="Tanguay, Jean Francois" sort="Tanguay, Jean Francois" uniqKey="Tanguay J" first="Jean Francois" last="Tanguay">Jean Francois Tanguay</name></author><author><name sortKey="Windecker, Stephan" sort="Windecker, Stephan" uniqKey="Windecker S" first="Stephan" last="Windecker">Stephan Windecker</name></author><author><name sortKey="Garratt, Kirk N" sort="Garratt, Kirk N" uniqKey="Garratt K" first="Kirk N." last="Garratt">Kirk N. Garratt</name></author><author><name sortKey="Kandzari, David E" sort="Kandzari, David E" uniqKey="Kandzari D" first="David E." last="Kandzari">David E. Kandzari</name></author><author><name sortKey="Lee, David P" sort="Lee, David P" uniqKey="Lee D" first="David P." last="Lee">David P. Lee</name></author><author><name sortKey="Simon, Daniel I" sort="Simon, Daniel I" uniqKey="Simon D" first="Daniel I." last="Simon">Daniel I. Simon</name></author><author><name sortKey="Iancu, Adrian Corneliu" sort="Iancu, Adrian Corneliu" uniqKey="Iancu A" first="Adrian Corneliu" last="Iancu">Adrian Corneliu Iancu</name></author><author><name sortKey="Trebacz, Jaroslaw" sort="Trebacz, Jaroslaw" uniqKey="Trebacz J" first="Jaroslaw" last="Trebacz">Jaroslaw Trebacz</name></author><author><name sortKey="Mauri, Laura" sort="Mauri, Laura" uniqKey="Mauri L" first="Laura" last="Mauri">Laura Mauri</name></author></analytic><series><title level="j">JAMA</title><idno type="ISSN">0098-7484</idno><idno type="eISSN">1538-3598</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Importance</title><p id="P1">Despite antirestenotic efficacy of coronary drug-eluting stents (DES) compared with bare metal stents (BMS), the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Although dual antiplatelet therapy (DAPT) beyond one year provides ischemic event protection following DES, ischemic event risk is perceived to be less following BMS and the appropriate duration of DAPT following BMS is unknown.</p></sec><sec id="S2"><title>Objective</title><p id="P2">To compare: (1) rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE; composite of death, myocardial infarction, or stroke) after 30 vs. 12 months of thienopyridine in patients treated with BMS taking aspirin; and (2) treatment duration effect within the combined cohorts of randomized DES or BMS-treated patients as prespecified, secondary analyses of the Dual Antiplatelet Therapy Study.</p></sec><sec id="S3"><title>Design, Setting, Participants</title><p id="P3">International, multicenter, randomized, double-blinded, placebo-controlled trial, comparing extended (30 months) thienopyridine versus placebo in aspirin-treated patients who completed 12 months of DAPT without bleeding or ischemic events post-stenting. Study initiation August 2009 with last follow-up visit May 2014.</p></sec><sec id="S4"><title>Exposure/Intervention</title><p id="P4">Continued thienopyridine or placebo at months 12-30 after stenting, in 11648 randomized patients treated with aspirin, of whom 1687 received BMS and 9961 DES.</p></sec><sec id="S5"><title>Main Outcome and Measures</title><p id="P5">Stent thrombosis, MACCE, moderate/severe bleeding.</p></sec><sec id="S6"><title>Results</title><p id="P6">Among 1687 BMS-treated patients randomized to continued thienopyridine vs. placebo, rates of stent thrombosis were 0.5% vs. 1.11%, (N=4 vs. 9, hazard ratio 0.49, 95% CI 0.15-1.64, P=0.24), MACCE 4.04% vs. 4.69%, (N=33 vs. 38, hazard ratio 0.92, 95% CI 0.57-1.47, P=0.72) and moderate/severe bleeding 2.03% vs. 0.90% (N=16 vs. 7, P=0.07), respectively. Among all 11,648 randomized patients (both BMS- and DES-treated), stent thrombosis rates were 0.41% vs. 1.32%, (N=23 vs. 74, hazard ratio 0.31, 95% CI 0.19-0.50, P<0.001), MACCE 4.29% vs. 5.74% (N=244 vs. 323, hazard ratio 0.73, 95% CI 0.62-0.87, P<0.001), and moderate/severe bleeding 2.45% vs. 1.47% (N=135 vs. 80, P<0.001).</p></sec><sec id="S7"><title>Conclusions and Relevance</title><p id="P7">Among patients undergoing coronary stenting with BMS and who tolerated 12 months of thienopyridine, continuing thienopyridine for an additional 18 months compared with placebo did not result in statistically significant differences in rates of stent thrombosis, MACCE, or moderate/severe bleeding. However, the BMS subset may have been underpowered to identify such differences and further trials are suggested. (DAPT ClinicalTrials.gov number NCT00977938).</p></sec></div></front></TEI><affiliations><list></list><tree><noCountry><name sortKey="Cutlip, Donald E" sort="Cutlip, Donald E" uniqKey="Cutlip D" first="Donald E." last="Cutlip">Donald E. Cutlip</name><name sortKey="Darius, Harald" sort="Darius, Harald" uniqKey="Darius H" first="Harald" last="Darius">Harald Darius</name><name sortKey="Driscoll Shempp, Priscilla" sort="Driscoll Shempp, Priscilla" uniqKey="Driscoll Shempp P" first="Priscilla" last="Driscoll-Shempp">Priscilla Driscoll-Shempp</name><name sortKey="Garratt, Kirk N" sort="Garratt, Kirk N" uniqKey="Garratt K" first="Kirk N." last="Garratt">Kirk N. Garratt</name><name sortKey="Gershlick, Anthony H" sort="Gershlick, Anthony H" uniqKey="Gershlick A" first="Anthony H." last="Gershlick">Anthony H. Gershlick</name><name sortKey="Iancu, Adrian Corneliu" sort="Iancu, Adrian Corneliu" uniqKey="Iancu A" first="Adrian Corneliu" last="Iancu">Adrian Corneliu Iancu</name><name sortKey="Kandzari, David E" sort="Kandzari, David E" uniqKey="Kandzari D" first="David E." last="Kandzari">David E. Kandzari</name><name sortKey="Kereiakes, Dean J" sort="Kereiakes, Dean J" uniqKey="Kereiakes D" first="Dean J." last="Kereiakes">Dean J. Kereiakes</name><name sortKey="Lee, David P" sort="Lee, David P" uniqKey="Lee D" first="David P." last="Lee">David P. Lee</name><name sortKey="Massaro, Joseph M" sort="Massaro, Joseph M" uniqKey="Massaro J" first="Joseph M." last="Massaro">Joseph M. Massaro</name><name sortKey="Mauri, Laura" sort="Mauri, Laura" uniqKey="Mauri L" first="Laura" last="Mauri">Laura Mauri</name><name sortKey="Meredith, Ian T" sort="Meredith, Ian T" uniqKey="Meredith I" first="Ian T." last="Meredith">Ian T. Meredith</name><name sortKey="Ormiston, John" sort="Ormiston, John" uniqKey="Ormiston J" first="John" last="Ormiston">John Ormiston</name><name sortKey="Simon, Daniel I" sort="Simon, Daniel I" uniqKey="Simon D" first="Daniel I." last="Simon">Daniel I. Simon</name><name sortKey="Steg, P Gabriel" sort="Steg, P Gabriel" uniqKey="Steg P" first="P. Gabriel" last="Steg">P. Gabriel Steg</name><name sortKey="Tanguay, Jean Francois" sort="Tanguay, Jean Francois" uniqKey="Tanguay J" first="Jean Francois" last="Tanguay">Jean Francois Tanguay</name><name sortKey="Trebacz, Jaroslaw" sort="Trebacz, Jaroslaw" uniqKey="Trebacz J" first="Jaroslaw" last="Trebacz">Jaroslaw Trebacz</name><name sortKey="Windecker, Stephan" sort="Windecker, Stephan" uniqKey="Windecker S" first="Stephan" last="Windecker">Stephan Windecker</name><name sortKey="Yeh, Robert W" sort="Yeh, Robert W" uniqKey="Yeh R" first="Robert W." last="Yeh">Robert W. Yeh</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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